Identification of Potent Bioassay Guided Terpenoid and Glycoside Root Fractions of Astragalus candolleanus against Clinically Significant Bacterial Strains.

Antibiotic resistance represents one of the biggest challenges, and there is an urgent need for plant-based antimicrobial agents that enable managing this crisis effectively. In this work, we aimed to investigate the antibacterial activity of Astragalus candolleanus (A. candolleanus) hydromethanolic root extract against Gram-positive (Bacillus subtilis and Staphylococcus aureus) and Gram-negative (Escherichia coli, Salmonella typhimurium, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Kocuria rhizophila) strains by the cup-plate method. The root was powdered and extracted with 70% methanol by cold maceration for 5 days. Preliminary phytochemical screening was performed with different solvents in the order of increasing polarity. Pure compounds were isolated by column chromatography and were characterized through liquid chromatography-mass spectrometry. Targeted predictions of the isolated compounds were also studied using Swiss Target prediction software and prediction of activity spectra for substances. The extract showed a broad zone of inhibition against pathogenic bacteria. Four pure compounds were isolated, of which a novel terpenoid compound has been identified as stemmadenine along with scillirosidin, cephalotaxine, and myxoxanthophyll. The structures of the isolated phytoconstituents were elucidated by spectral analysis. The four pure components isolated from the roots of A. candolleanus are suggested to be effective against tested pathogens. Overall results of drug design suggest that myxoxanthophyll is a promising bioactive compound endowed with antibacterial activity.

Status of documentation grading and completeness score for Indian individual case safety reports.

The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.94 out of 1.0. Periodical training on emphasizing the quality ICSRs is need of the hour.

Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India.

BACKGROUND: The Pharmacovigilance Programme of India (PvPI) is responsible for collecting reports of adverse drug reactions (ADRs) to assess the association between particular drugs and ADRs. The aim of the present study was to apply statistical tools to determine associations between drugs and ADRs for signal detection in the PvPI. METHODS: Four methods were proposed for quantitative signal detection: one was based on Bayesian inference and others on classical inference procedures. The effectiveness of the proposed methods was assessed by applying them to 4 drug-ADR combinations. RESULTS: The proposed methods were easy to apply and relevant to the Indian context. In selected methods, the information component value was more specific, whereas the proportional relative risk was more sensitive. CONCLUSIONS: The proposed methods may help in the identification of new signals in Indian individual case safety reports.